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NCT06852976 · ClinicalTrials.gov registry record · Phase 2

A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers

A Phase 2 study of Diabetic Foot Ulcer, sponsored by Zhuhai Rui-Inno Pharmaceutical Technology Co..

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06852976: Recruiting Phase 2 study of Diabetic Foot Ulcer, sponsored by Zhuhai Rui-Inno Pharmaceutical Technology Co..

NCT06852976 is a Phase 2 study of Diabetic Foot Ulcer that is actively recruiting participants, run by Zhuhai Rui-Inno Pharmaceutical Technology Co.. The registered enrollment target is 60 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06852976, a Phase 2 study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Zhuhai Rui-Inno Pharmaceutical Technology Co..

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.

Primary Outcome

Incidence (severity and causality) of any drug related local and systemic treatment emergent adverse events (TEAE) for 12 weeks during the study treatment.

Conditions Studied

Interventions

  • DRUG 0.75% MDI-1228_mesylate gel plus Standard of Care
  • OTHER Standard of Care Alone

Study Locations (1)

North Carolina

  • Site 001 - Durham

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-03-12
Est. Completion 2025-12
Phase Phase 2

What NCT06852976 shows while recruiting

NCT06852976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which 0.75% MDI-1228_mesylate gel plus Standard of Care is the first listed.

NCT06852976 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT06852976 about?

NCT06852976 is a clinical study titled "A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers". The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50...

What is the current status of trial NCT06852976?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-03-12. Estimated completion is 2025-12.

What conditions does trial NCT06852976 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer.

What interventions are being tested in trial NCT06852976?

The interventions under investigation include: 0.75% MDI-1228_mesylate gel plus Standard of Care (DRUG), Standard of Care Alone (OTHER).

Who is sponsoring clinical trial NCT06852976?

This trial is sponsored by Zhuhai Rui-Inno Pharmaceutical Technology Co., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06852976 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetic Foot Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06852976's enrollment target sits among peer trials

60 44th of 67 higher than 21 of 67 other Diabetic Foot Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06852976, the US trial registry maintained by the National Library of Medicine. NCT06852976 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.